Experience of QC analytical, LIMS software handling, Master preparation in LIMS, preferably ONE Lab and Labware. Candidates may also apply who has good hands on experience on Caliber, StartLIMS , Labvantage or other LIMS.
M.Pharm, B.Pharm, M.Sc, B.Sc ; Should have experience in operating and cleaning a Vial Washing machine, Depyrogenation Tunnel, Automatic Vial Filling and Sealing Machines, and Automatic PFS filling machines.
Should have leadership quality with thorough knowledge of shop floor, equipments, qualifications, QMS with investigation, problem solving skills and Training skills. Should able to handle team. Should have good communication skills.
To make respective area all time ready for audit.
Generate codes, issue control and un-control copies, and prepare master documents. Coordinate with F&D, ADL, and Quality Control for document management. Review SOP, Incident, Risk Assessment, Market Complain and Investigation.
BPharm or MPharm require; Review of Protocols and reports related to Analytical method validation, Verification of API and Finished product, Vendor qualification, cleaning validations. Hypothesis analysis, general validations, Stability, photo stability, thermal cycling, in use, split study and miscellaneous studies and approval in LIAAS where ever applicable.
Review of technology transfer documents and initiate the validation accordingly in plant scale by coordinating with CFT. Review of Master Batch Manufacturing records executed Batch manufacturing records.